MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 16MM; KNEE ENDOPROSTHETICS

Model Number NR883M

Device Problems Fracture (1260); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 08/09/2020

Event Type  Injury  

Manufacturer Narrative

Investigation on going.Additional information / results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with enduro meniscal.According to the complaint description, it was reported that fracture of axis occured.Both axis and inlay changed.The primary implantation of the prosthesis was on (b)(6) 2012 in the (b)(6).The first inlay and axis revision due to suspicion of infection was on (b)(6) 2014, the second for the same reason on (b)(6) 2017, both in (b)(6).Now the third revision on (b)(6) 2020, the axis and the inlay changed, but the existing locknut was reused.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the rotation axis has fractured above the taper, directly below the screw thread.The taper of the rotation axis shows little visible damage on the surface.The breakage surface of the larger distal part of the axis shows massive secondary damage.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.On the basis of the current information, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the baisis of the device history records.We assume that the loosening of the rotation axis locking nut occurred prior to the breakage of the rotation axis.A root cause for the loosening of the nut could be that, when the connection between the axis taper and the femur was not firmly fitted, there is a gap and hence movement between the components.This leads to the femur safety nut unscrewing and then - as a consequence - to the axis breaking above the taper.The load transfer in this case is transmitted through narrowest part of the axis not through the main axis.Furthermore it could be possible that a special patient situation, for example disturbance in coordination lead to extreme bending moments and contribute a fracture.Based on the investigations and results of the 8d report no capa is necessary.

• Brand Name: ENDURO MENISCAL COMPONENT F2 16MM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10563903
• MDR Text Key: 208341739
• Report Number: 9610612-2020-00490
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: NR883M
• Device Catalogue Number: NR883M
• Device Lot Number: 52336148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR